The efficacy of Silybum marianum (L.) Gaertn. (silymarin) in the treatment of type II diabetes: a randomized, double-blind, placebo-controlled, clinical trial

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[Note: Silybum marianum/silymarin is milk thistle extract.] Journal: Phytotherapy Research. Vol. 20, Issue 12, pp.1036-1038 (December 2006). Published online ahead of print October 30, 2006. Authors and affiliations: H. Fallah Huseini, B. Larijani, R. Heshmat, H. Fakhrzadeh, B. Radjabipour, T. Toliat, Mohsin Raza. Department of Pharmacology, Institute of Medicinal Plants, ACECR Tehran (Huseini); Endocrinology and Metabolism Research Center, Tehran University of Medical Sciences, Tehran (Larijani, Heshmat, Fakhrzadeh, Radjabipour); School of Pharmacy, Tehran University of Medical Sciences, Tehran (Toliat); Department of Physiology, School of Medical Sciences, Tarbiat Modares University, Tehran (Raza) – Iran. [E-mail: H. Fallah Huseini (huseini_fallah@yahoo.com ) Sponsor: Endocrinology and Metabolism Research Center, Tehran University of Medical Sciences Tehran Iran; Grant Number: R507/2003 DOI: 10.1002/ptr.1988

Oxidative stresses are increasingly implicated in the pathogenesis of diabetic complications which may either cause direct pancreatic beta-cell damage or lead to metabolic abnormalities that can induce or aggravate diabetes. The valuable effect of antioxidant nutrients on the glycemic control of diabetic patients has been reported in experimental and clinical studies.

The present study was designed to investigate the effects of the herbal medicine, Silybum marianum seed extract (silymarin), which is known to have antioxidant properties on the glycemic profile in diabetic patients. A 4-month randomized double-blind clinical trial was conducted in 51 type II diabetic patients in two well-matched groups. The first group (n = 25) received a silymarin (200 mg) tablet 3 times a day plus conventional therapy. The second group (n = 26) received the same therapy but a placebo tablet instead of silymarin. The patients were visited monthly and glycosylated hemoglobin (HbA1c), fasting blood glucose (FBS), insulin, total cholesterol, LDL and HDL, triglyceride, SGOT and SGPT levels were determined at the beginning and the end of the study.

The results showed a significant decrease in HbA1c, FBS, total cholesterol, LDL, triglyceride SGOT and SGPT levels in silymarin treated patients compared with placebo as well as with values at the beginning of the study in each group.

In conclusion, silymarin treatment in type II diabetic patients for 4 months has a beneficial effect on improving the glycemic profile.

Keywords: silymarin, herbal medicine, antioxidant, diabetes

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